Kornimate/medical-research-clean huggingface dataset:
autologous fibroblast transplantation in facial deformities

Conditions: Nasolabial Folds; Glabellar Crease; Deep Wrinkles of the Forehead; Acne Scars

Summary: beautiful skin requires maintenance of proper care. skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. however despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.

autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. prior to final packaging, cell viability is assessed to be at least 85%. each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 ml of sterile, buffered dulbecco's modified eagles medium (dmem). both the biopsy transport media and the cell culture media contain gentamicin. residual quantities of gentamicin up to 5 µg/ml may be present in the cell product

Eligibility criteria:
inclusion criteria: * available and willing to attend all follow-up visits. * age \> 18 years. * able and willing to give informed consent. exclusion criteria: * known allergy or sensitivity to collagen fillers * the subject has received a soft tissue augmentation to the area to be treated within the last 6 months. * subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study. * the subject has received autologous fat transfer in the last 6 months. * subject is suffering from facial kaposi's sarcoma. * the subject has active skin diseases or inflammation on or near the area of injection * positive hiv, hbv, hcv

Keywords: fibroblast cell transplantation facial deformities
the national diabetes prevention program in rural communities

Conditions: PreDiabetes; Weight Loss; Lifestyle Risk Reduction

Summary: the purpose of this pilot trial is to compare feasibility and effectiveness of remote delivery (social media or video conferencing) of the national diabetes prevention program (n-dpp) to adults in rural communities. the research team will train a kansas state research and extension staff to deliver the video conferencing arm while a research team member will lead the social media arm.

this pilot trial will compare the feasibility and effectiveness of dpp delivered through facebook (dpp-fb) or group format delivered remotely by zoom (dpp-r) in adults in rural communities. both interventions will recruit through the corporative extension service (ces), which serves as the community outreach arm of all land grant universities through over 2,900 offices across the u.s. the kansas state research and extension (ksre) (kansas version of ces), is well positioned, but underutilized for the delivery of dpp in rural areas. delivery of dpp by a well-recognized entity, such as the ksre, may improve the probability of dissemination and long-term program sustainability. two ces offices serving rural counties in kansas will be randomized (1:1) to the dpp-fb or dpp-r arms. our research team will train one professional staff from ksre (with backgrounds in nutrition programming and family consumer science) to deliver the dpp-r intervention. a research team member will deliver the dpp-fb intervention. this project will address the following aims: primary aim: compare weight and mvpa between dpp-fb and dpp-r across 6 mos. the investigators expect greater weight loss and mvpa in the dpp-r arm compared with the dpp-fb arm. secondary aim: compare the feasibility of dpp-fb and dpp-r across 6 mos. based on participant retention and program attendance. the investigators expect greater participant retention and program attendance in the dpp-r arm compared with the dpp-fb arm.

Eligibility criteria:
inclusion criteria: 1. prediabetes as defined as a1c = 5.7-6.4%, fasting glucose = 100-125 mg/dl, (confirmed from physician/medical record in the previous year), history of gestation diabetes mellitus or a positive result based on the cdc- dpp screener 2. age ≥18 yrs. 3. willing to commit to participate on a weekly basis for the 6 month intervention 4. living in the county of a rural ksre local unit. rural counties will be defined using the american community survey definition which categorizes a county as rural if the population is \< 65,000 5. internet access and capability to use zoom 6. clearance from primary care physician exclusion criteria: 1. diagnosis of type 2 diabetes 2. unable to participate in physical activity.
comparative efficacy of different time interval between rtms and rehabilitation program for motor recovery in stroke patients

Conditions: Stroke

Summary: comparative efficacy of different time interval between rtms and rehabilitation program for motor recovery in stroke patients

stroke is one of the main causes of death and disability in taiwan. the m1 excitability of the affected hemisphere decreases, while that of the unaffected hemisphere increases, leading to further interhemispheric inhibition. repetitive transcranial magnetic stimulation (rtms) is a non-invasive neuromodulation technology. high and low frequencies of rtms could modulate the excitability of the cerebral cortex. through regulating the excitability of bilateral hemispheres, rtms could facilitate motor recovery in stroke patients. previous study had been demonstrated that priming rehabilitation program with low frequent rtms would lead to better motor recovery in the chronic stroke patients. however, the optimal time interval between the rtms and the rehabilitation program had not been investigated. thus, this study will utilize low frequent rtms, targeting the intact hemisphere, to investigate the clinical effects and motor cortex excitability under different time intervals between the rtms and the rehabilitation program. this study is designed as a randomized controlled trial. we plan to recruit 45 subacute stroke patients with hemiplegia. the patients are randomly assigned to three groups. in the group 1, the patients receive contralateral 1 hz rtms stimulation and subsequent rehabilitation program. in the group 2, the patients receive contralateral 1 hz rtms, but the rehabilitation will be delayed at least two hours after the rtms stimulation. the control group receive sham rtms and subsequent rehabilitation program. the treatment schedule for all groups will be five times per week for a two-week course, which means a total of ten sessions. the primary outcome is upper limb fugl-meyer assessment. the secondary outcomes included medical research council (mrc) scale, barthel scale, modified rankin scale (mrs), cortical excitability assessment (including bilateral maximum mep amplitude, mep latency, and bilateral resting motor threshold). follow-up time points are before rtms and at 1st, 4th, 12th weeks after the end of the treatments.

Eligibility criteria:
inclusion criteria 1. \>=20 years old, unilateral stroke diagnosed by ct or mri 2. post-stroke 1 week to 6 months 3. medical research council scale for muscle strength in upper limb ≤ 3 4. no history of previous stroke, seizure, dementia, parkinsonism or other neurodegenerative disease 5. stable medical condition and vital signs exclusion criteria 1. previous stroke, traumatic brain injury, brain tumor 2. with central nervous system disease (spinal cord injury, parkinson's disease) 3. any contraindication to rtms (seizure, alcoholism, metal implant, pacemaker, pregnancy...) 4. patients unable to cooperate the treatment

Keywords: rtms stroke
a randomized, phase i, cross-over study to assess the relative bioavailability of single-dose cobimetinib (gdc-0973) in tablet vs. capsule formulation

Conditions: Healthy Volunteer

Summary: this study will be a phase 1, open-label, randomized, 2-period, 2-treatment sequence crossover study to determine the relative bioavailability of cobimetinib administered as a single dose of the tablet formulation relative to a single dose of the capsule formulation to healthy male and female participants. a minimum of 24 participants (12 participants per sequence) will complete the study. participants will be randomly assigned to 2 possible sequences (i.e., i: a/b, ii: b/a) where the treatments are as follows: treatment a: one cobimetinib tablet administered as a single oral dose after at least an 8-hour fast; treatment b: four cobimetinib capsules administered as a single oral dose after at least an 8-hour fast. the study is expected to last approximately 7 weeks.


Eligibility criteria:
inclusion criteria: * healthy male and female volunteers between 18 and 55 years of age, inclusive * body mass index between 18.5 to 32.0 kg/m2, inclusive; * adequate renal, liver, and hematologic function * participants who are in good health as determined by no clinically significant findings from medical history, 12-lead ecg, vital signs, and clinical laboratory evaluations exclusion criteria: * significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the investigator)
investigation of psychophysiological response to aversive stimuli over time with omega-3

Conditions: Conduct Disorder; ADHD; Oppositional Defiant Disorder

Summary: this study investigates the psychophysiological responses to aversive stimuli in a population of 133 children clinically diagnosed with conduct disorder (cd) and/or attention-deficit/hyperactivity disorder (adhd). participants were administered with either omega-3 or placebo for a period of 6 months and were exposed to three stimuli every three months: 1) a loud sound, 2) threatening photographs from the international affective picture system (iaps), and 3) the trier social stress task (tsst). participants' psychophysiological features of heart rate and galvanic skin conductance were measured and analyzed in relation to their omega-3/placebo condition clinical diagnosis.


Eligibility criteria:
inclusion criteria: 1. subjects between ages 7 and 16 years 2. subjects who fulfil all criteria for a dsm-iv diagnosis of adhd, conduct disorder, or oppositional defiant disorder 3. subjects with willingness to participate in a randomized, double-blind controlled trial 4. subjects with complete written, informed parental consent and child assent 5. subjects with iq of 70 or more exclusion criteria: 1. subjects who have iq in the below 70 2. subjects who are younger than 7 years old or older than 16 years old 3. those without written parental consent 4. those with brain pathology such as serious head injury, epilepsy, etc.
non-pharmacological pain care during complex wound care procedures

Conditions: Wound Surgical; Wounds and Injuries; Virtual Reality; Wound Care; Music Therapy

Summary: the main objective of this study is to evaluate the effect on pain and both virtual reality and music therapy as add-on therapy during wound car in adults.

after inclusion and completion of the informed consent form, patients are randomly allocated to the intervention group or control group in a 1:1:1 ratio. randomization will not be blinded since both the provider and patient know if the patient will be wearing the vr system or headphone with audio during wound care or not wearing the vr system or headphone with audio. patients are randomly assigned to one of three groups: group 1 - intervention group 1, virtual reality therapy group 2 - intervention group 2, music therapy group 3 - control group, care as usual

Eligibility criteria:
inclusion criteria: * individuals aged 18 or older who have wounds receiving wound care * individuals who will undergo minimum of 1 to a maximum of 3 sequential complex wound care procedures before discharge * at least 1 prior painful wound care procedure, where they have indicated a vas ≥ 4, or patients reporting a vas ≥ 4 before initiating the wound care procedure. exclusion criteria: * individuals not being able to understand dutch language at primary school level * individuals not being able to read or write dutch * individuals diagnosed with dementia and/or cognitive impairment * individuals diagnosed with epilepsy * individuals diagnosed with migraine * individuals with severe dizziness and/or nausea * individuals with a known history of claustrophobia * individuals who are unable to sign informed consent owing to mental disorder or formally stated to be incompetent to decide * individuals who have no feeling in the wound care area * individuals with physical (and/or cognitive) disabilities on the face, eye, ear, nose and neck that prevent the use of the vr headgear and/or headphones
effect of intensive therapy associated with csii on β-cell function with newly diagnosed type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily injections,) on glycemic control, b-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 2 diabetes, exclusion criteria: * received previous antihyperglycaemic therapy

Keywords: ype 2 diabetes mellitus, continuous subcutaneous insulin infusion, α-lipoic acid ,rosiglitazone ,metformin，therapy
molecular background of endothelial cell loss in patients with phakic intraocular lenses: a tear and aqueous humour analysis study

Conditions: Cataract; Phakic Intraocular Lens Explantation

Summary: rationale: the number of highly myopic patients is increasing. especially in east and southeast asia, up to 90% of adolescents are currently myopic. long-term treatment of high myopia can be obtained by three types of surgery: laser refractive surgery, phakic intraocular lens (piol) implantation, and refractive lens exchange implantation with a piol is the preferred treatment for high myopes, resulting in increasing patient numbers implanted due to the increasing numbers of patients with high myopia. long-term results show that implantation of a piol induces an accelerated decrease in corneal endothelial cells (ec). although some risk factors for increase ec loss have been identified, the underlying mechanism is currently unknown. it is hypothesized that the aqueous flow in the anterior segment of the eye (i.e. anterior chamber) is disturbed, causing an altered nutritional flow in the anterior chamber. another hypothesis is that the piol causes chronic subclinical inflammation in the anterior chamber resulting in increased ec loss. currently there is insufficient proof to confirm or reject either hypothesis. if one of these hypotheses can be confirmed, it is likely to induces significant changes in clinical practice. objective: the primary objective of the study is to explore the role of inflammation in the anterior chamber on endothelial cell loss in patients implanted with iris-fixated piols. the secondary objective is to identify whether there is a correlation between biomarkers in aqueous humour and biomarkers in tears, both related to the accelerated progression of ec loss. study design: two strategies are incorporated in the design of this study. the first part will retrospectively evaluate ec loss in patients with iris-fixated (if) phakic intraocular lenses (piols). the second part is prospective and will compare ec measurements, cytokines in aqueous humour and in tears from patients scheduled for if-piols explantation and compare them to patients with routine cataract surgery. study population: patients over 18 years of age, undergoing regular cataract surgery, and patients undergoing piol explantation in combination with cataract surgery. a total number of 126 patients is needed, equally divided over two groups.


Eligibility criteria:
inclusion criteria: * age over 18 * cataract in one or both eyes, or indication for piol explantation * informed and having given informed consent. exclusion criteria: * insufficient understanding of the dutch language to comply with study procedures * inability to complete follow-up or comply with study procedures * non-routine cataract surgery * cognitive or behavioral conditions that might interfere with surgery * patients with ocular comorbidities such as * women who are pregnant or nursing their child * immune-compromised patients (e.g., systemic corticosteroid use, leukaemia) * factors that increase the risk of complicated surgery
development of a clinical trial specific question prompt list

Conditions: Breast Cancer; Lung Cancer; Prostate Cancer

Summary: the purpose of this study is to develop a question prompt list (qpl) about clinical trials for cancer patients and find out what cancer patients and their caregivers think of the qpl. a qpl is a list of questions patients might want to ask their doctors during their appointments. we will conduct three focus groups to talk about using qpl's as a new way to recruit patients like you to clinical trials. the three groups will be made of patients who have and have not participated in clinical trials, their caregivers and doctors. this study is also being done to learn about how the qpl affects the question asking behavior of patients during their appointments with doctors at memorial sloankettering cancer center (mskcc).


Eligibility criteria:
inclusion criteria: * population segment 1 who have participated in a clinical trial * diagnosis and treatment at mskcc of lung, prostate or breast cancer * completion of a phase i, ii, or iii clinical trial at mskcc * ability to provide informed consent patient caregiver eligibility requirements will be: * nomination by patient as the primary caregiver * ability to provide informed consent population segment 2 who have not participated in a clinical trial: * diagnosis and treatment at mskcc of lung, prostate or breast cancer or the primary patient caregiver * ability to provide informed consent patient caregiver eligibility requirements will be: * nomination by patient as the primary caregiver * ability to provide informed consent population segment 3 who are health care professionals: * a current health care professional at mskcc * current involvement in recruiting patients with lung, prostate or breast cancer to phase i,ii, or iii clinical trials at mskcc * ability to provide informed consent exclusion criteria: potential subjects will be considered ineligible for either/both phases of this study if they are: * fewer than 18 years of age * cognitively or physically impaired, rendering them incapable of providing informed consent to participate in the study * population segment 2 participants will be excluded if they have ever participated in a clinical trial.
intramuscular injections of botulinum toxin in lateral pterygoid muscle in the treatment of temporomandibular dysfunctions: studying the interest of mri guidance and ultrasound guidance

Conditions: Mandibular Dysfunction

Summary: the main hypothesis is that a significant pain improve (measured with visual analogic scale \[vas\]) can be observed after injection of botulinum toxin a, meaning the success of the guidance device.


Eligibility criteria:
inclusion criteria: * patients suffering from muscular temporomandibular dysfunctions (tmd) with clinical diagnosis: myofascial pain, limited opening of the mouth, articular noise. * \>= 18 years old * with signed informed consent form exclusion criteria: * articular tmd: arthritis or other inflammatory disease of temporomandibular joint, arthrosis, bone deformation, previous fracture of condylar area ; * electromyographic hypoactivity, pure muscular diseases ; * oro-mandibular dystonia ; * botulinum toxin allergy, * risk of bleeding * recent or active infection * intercurrent antibiotic treatment (drug interaction) ; * vaccination during the 15 days preceding the injection.
neural correlates for therapeutic mechanisms of lithium in bipolar disorder

Conditions: Bipolar Disorder

Summary: the investigators will assess li-induced gray matter volume changes with regard to the endophenotype of gsk3beta polymorphism. the changes of gray matter are supposed to be more attributable to neurotrophic and neuroprotective characteristics of li, which were closely related to the inhibition of apoptotic activity of gsk3beta.


Eligibility criteria:
inclusion criteria: * men and women aged between 19 and 55 * diagnosis of bipolar i disorder as assessed by the structured clinical interview for dsm-iv (scid-iv) * patients who have not used psychoactive medications for more than 2 weeks * individuals who provided written consent for participation exclusion criteria: * presence of any major physical or neurological illness (e.g., head trauma, epilepsy, seizure, stroke, cerebral tumor, multiple sclerosis, cerebrovascular disease, narrow-angle glaucoma, drug hypersensitivity, etc.) * women who are pregnant, breastfeeding, or planning pregnancy * diagnosis of any axis i disorder other than bipolar disorder * intelligence quotient below 80 * current or past drug abuse * contraindications to magnetic resonance imaging (e.g., pacemaker implantation, claustrophobia, etc.)

Keywords: lithium bipolar disorder multimodal brain imaging
a phase 2 multicenter randomized clinical trial of cntf for mactel

Conditions: Macular Telangiectasia Type 2

Summary: this study is a phase 2, randomized, multi-center, single-masked study to evaluate the efficacy and safety of the nt-501 implants in participants with mactel.


Eligibility criteria:
inclusion criteria: * participant must be offered sufficient opportunity to review and to understand the informed consent form, agree to the form's contents and sign the protocol's informed consent * participant must have at least one study eye with a positive diagnosis of mactel type 2 * participant must have an is/os pr break in the study eye(s) and en face ellipsoid zone (area of is/os loss) as measured by sdoct between 0.16 mm2 and 4.00 mm2 * if female, participant must be incapable of pregnancy * if male, participant must agree to use an effective form of birth control during the study exclusion criteria: * participant is unable to provide informed consent * participant is less than 21 years of age or greater than 80 years of age * participant is medically unable to comply with study procedures or follow-up visits * participant was a study subject in any other clinical trial of an intervention (drug or device) within the last 6 months * participant is pregnant or breastfeeding

Keywords: mactel